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FDA Orange Book · active-ingredient family

Dichlorphenamide

Dichlorphenamide is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DARANIDE · NDA 011366

1

Brand (NDA)

2

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
DARANIDERLD×2XERISNDA 011366Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
DICHLORPHENAMIDERISINGANDA 218783ABNov 18, 2025
ORMALVITORRENTANDA 215924ABDec 29, 2022

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Dichlorphenamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.